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Reirradiation and Erbitux in the HNSCC

NCT ID: NCT01237483

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-07-05

Brief Summary

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The purpose of this study is to investigate in patients with cancer of the throat and recurrent inoperable a different modality treatment consisting of radiation continuously for 5 weeks and half associated with a drug directed against a receptor on cell surfaces cancer, called Erbitux ®.

The investigators hope with this shorter treatment (1.5 weeks less than the usual treatment) to improve the antitumor efficacy without additional toxic side effects.

Detailed Description

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We hope with this treatment improved antitumor efficacy without additional toxic side effects, while being shorter than 1.5 weeks of standard therapy. But this is an hypothesis we can not meet the current state of knowledge, which justifies this study.

The main hypothesis is that this combination of reirradiation and Cetuximab give a relative gain of 15% complete response rate.

Conditions

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Head and Neck Cancer Squamous Cell

Keywords

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reirradiation with Erbitux HNSCC local recurrent inoperable Squamous Cell Cancer of the Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erbitux Radiotherapy

Radiotherapy during 5 weeks and concurrent Erbitux once a week.

Group Type OTHER

Erbitux

Intervention Type DRUG

To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)

Interventions

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Erbitux

To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with unresectable locoregional recurrence of squamous cell carcinoma in a previously irradiated area (at least 75% of the volume of recidivism must be in an area who have received at least 50 Gy)
* The entire tumor volume can be included in a radiation field without the total dose to the spinal cord more than 50 Gy (dose + dose earlier predicted)
* Patient with recurrent or second location in the oral cavity, oropharynx, larynx, hypopharynx, cervical lymph nodes or tissues, without distant metastases,
* Minimum 12 months after the end of radiotherapy previous
* WHO performance status: 0-1,
* Evaluable disease by RECIST V.1.1.,
* Age between 18 and 75 years
* The patient may have received prior chemotherapy for relapse for more than five weeks,
* The patient may have received cetuximab for the treatment of disease but not for the first relapse,
* Hematologic function: ANC ≥ 1500/mm3, Platelets ≥ 100000/mm3,
* Normal renal function: serum creatinine ≤ 120 µmol/l and/or creatinine clearance \> 60 ml/min
* Normal liver function: bilirubin \<1.5 x ULN, alkaline phosphatase and transaminases \<2.5 x ULN,
* Normal cardiac function, assessed clinically. History of cardiovascular disease stabilized for over 12 months
* Cons-Lack of medical indications in the proposed treatment,
* The dosimetry of previous treatment should be available and the estimated dosimetry must be performed to check the constraints,
* All patients of childbearing age should receive effective contraception,
* Membership of a social security system (or be a beneficiary of such a plan) under the terms of the Act of August 9, 2004,
* Signed informed consent

Exclusion Criteria

* Tumors of the nasal cavity and paranasal,
* Tumors of other histological type,
* Stage IV with distant metastases or multiple tumors,
* Time after previous radiotherapy \<12 months,
* Less than 75% of the volume of relapse who have previously received at least 50 Gy,
* Any medical condition or general-cons would indicate the completion of treatment. Systemic disease or uncontrolled infection,
* History of cancer other than head and neck cancer, cutaneous basal cell, carcinoma in situ of the cervix
* Any other concurrent anticancer therapy,
* Patient receiving another molecule experimental
* Pregnant, lactating or without contraception;
* Persons deprived of liberty under guardianship
* Inability to undergo medical test for geographical, social or psychological
* Nasopharyngeal Neoplasms
* Patients with active ischemic heart disease or previous myocardial infarction within the last 12 months
* Late toxicity dermal or subcutaneous related to previous irradiation of grade\> 2 in the scale CTCAE V.4.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Oncologie Radiotherapie Tete et Cou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent MARTIN, oncologist

Role: STUDY_DIRECTOR

Centre Guillaume Le Conquérant, 76600 Le Havre, France

Claude TUCHAIS, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Paul Papin, 49933 Angers, France

Sauveur Marc ALFONSI, oncologist

Role: PRINCIPAL_INVESTIGATOR

Institut Sainte Catherine, 84082 Avignon, France

Xu Sh SUN, oncologist

Role: PRINCIPAL_INVESTIGATOR

Hôpital Jean Minoz, 25030 Besançon, France

Dominique DE RAUCOURT, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse, 14076 Caen, France

Michel LAPEYRE, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin, 63011 Clermond-Ferrand, France

Philippe MAINGON, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre G-F Leclerc, 21079 Dijon, France

Muriel GARCIA-RAMIREZ, oncologist

Role: PRINCIPAL_INVESTIGATOR

Hôpital Robert Boulin, 33505 Libourne, France

Christian SIRE, oncologist

Role: PRINCIPAL_INVESTIGATOR

Hôpital du Scorff, 56322 Lorient, France

Séverine RACADOT, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, 69373 Lyon, France

Véronique FAVREL, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud, 69495 Pierre-Benite, France

Etienne BARDET, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre René Gauducheau, 44805 Nantes-St Herblain, France

Philippe LANG, oncologist

Role: PRINCIPAL_INVESTIGATOR

Hôpital de La Pitié Salpitrière, 75013 Paris, France

Isabelle TENNEVET, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel, 76038 Rouen, France

Patricia BURBAN, oncologist

Role: PRINCIPAL_INVESTIGATOR

Clinique Armoricaine de Radiologie, 22015 St Brieuc, France

Olivier GALLOCHER, oncologist

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur, 31300 Toulouse, France

Olivier GALLOCHER, oncologist

Role: PRINCIPAL_INVESTIGATOR

Polyclinique du Parc, 31078 Toulouse, France

Yungan TAO, oncologist

Role: PRINCIPAL_INVESTIGATOR

Institut Gustave Roussy, 94805 Villejuif, France

Pierre BOISSELIER, oncologist

Role: PRINCIPAL_INVESTIGATOR

Val d'Aurelle 34298 Montpellier cedex

Frédéric PEYRADE, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne 06189 NICE cedex 2

Marie SALIOU, oncologist

Role: PRINCIPAL_INVESTIGATOR

Clinique de l' Estuaire 44600 Pornichet

Cédrik LAFOND, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Bernard 72000 Le Mans

René-Jean BENSADOUN, oncologist

Role: PRINCIPAL_INVESTIGATOR

CHU 86021 Poitiers cedex

Alexandre COUTTE, oncologist

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens sud 80004 Amiens

Hao QIU, oncologist

Role: PRINCIPAL_INVESTIGATOR

CHU 86000 Limoges

Florence HUGUET, oncologist

Role: PRINCIPAL_INVESTIGATOR

Hôpital Tenon 75020 Paris

Sébastien GUIHARD

Role: PRINCIPAL_INVESTIGATOR

Centre Paul Strauss 67065 Strasbourg

Xu Shan SUN, oncologist

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de Belfort Montbéliard Bd du Maréchal Juin 25200 Montbéliard

Locations

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Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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GORTEC 2008-01

Identifier Type: -

Identifier Source: org_study_id